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After FDA Approval, Boehringer Ingelheim Launching PGx NSCLC Drug Gilotrif in US


Boehringer Ingelheim commercially launched its pharmacogenomically targeted non-small cell lung cancer drug Gilotrif on Sept. 2 in the US.

The US Food and Drug Administration approved Gilotrif in July for the first-line treatment of metastatic NSCLC patients who harbor EGFR exon 19 deletions or exon 21 L858R substitutions (PGx Reporter 7/17/2013). The agency simultaneously approved Qiagen's Therascreen EGFR RGQ PCR Kit to help healthcare providers pick out patients who have these mutations and therefore have an increased chance of responding well to Gilotrif.

Before Gilotrif became commercially available, Boehringer was providing the drug through an expanded access program. Gilotrif is an oral irreversible kinase inhibitor that binds to and inhibits EGFR, HER2, and ErbB4.

In NSCLC lung cancer patients genetic mutations lead to constant activation of the EGFR protein which drives their cancer. Studies suggest that between 10 percent and 15 percent of Caucasians and around 40 percent of Asians have EGFR mutations. In 90 percent of these cases, the mutations are EGFR exon 19 deletions or exon 21 L858R substitutions.

Boehringer has also launched a patient access program, called Solutions Plus, for Gilotrif, through which the company will manage access issues and provide clinical support to patients. Before launching the drug, Boehringer introduced the “Let's Test” campaign to educate healthcare providers about biomarker testing in NSCLC and to encourage them to collect tissue samples from patients early in their treatment continuum (PGx Reporter 10/24/2012).